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Mr S Hurn

⚠️ Moderate Risk

FEI: 3004142681 • Solihull, West Midlands • UNITED KINGDOM

FEI

FEI Number

3004142681

📍

Location

Solihull, West Midlands

🇬🇧
🏢

Address

6 Loxley Avenue, , Solihull, West Midlands, United Kingdom

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
1
Unique Violations
12/18/2003
Latest Refusal
12/18/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
12/18/2003
61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/18/2003
60LCB69TRAMADOL HCL (ANALGESIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mr S Hurn's FDA import refusal history?

Mr S Hurn (FEI: 3004142681) has 2 FDA import refusal record(s) in our database, spanning from 12/18/2003 to 12/18/2003.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Mr S Hurn's FEI number is 3004142681.

What types of violations has Mr S Hurn received?

Mr S Hurn has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Mr S Hurn come from?

All FDA import refusal data for Mr S Hurn is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.